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Completed Phase 3 Interventional Results available

A Trial of AXS-05 in Patients With Major Depressive Disorder

ClinicalTrials.gov ID: NCT04019704

Public ClinicalTrials.gov record NCT04019704. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 16, 2026, 5:03 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

AXS-05-MDD-301: A Randomized, Double-Blind, Placebo-Controlled Trial of AXS-05 in Subjects With Major Depressive Disorder

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD).

Study identification

NCT ID
NCT04019704
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Enrollment
327 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 20, 2019 (Actual)
Primary completion
Nov 26, 2019 (Actual)
Completion
Dec 5, 2019 (Actual)
Last update posted
Oct 12, 2022

2019

United States locations

U.S. sites
43
U.S. states
18
U.S. cities
42
Facility City State ZIP Site status
Clinical Research Site Phoenix Arizona 85012 —
Clinical Research Site Phoenix Arizona 85016 —
Clinical Research Site Little Rock Arkansas 72209 —
Clinical Research Site Bellflower California 90706 —
Clinical Research Site Beverly Hills California 90210 —
Clinical Research Site Garden Grove California 92845 —
Clinical Research Site Oakland California 94607 —
Clinical Research Site Oceanside California 92056 —
Clinical Research Site Panorama City California 91402 —
Clinical Research Site Redlands California 92374 —
Clinical Research Site Riverside California 92506 —
Clinical Research Site San Diego California 92103 —
Clinical Research Site Sherman Oaks California 91403 —
Clinical Research Site Upland California 91786 —
Clinical Research Site Coral Springs Florida 33067 —
Clinical Research Site Hollywood Florida 33024 —
Clinical Research Site Jacksonville Florida 32256 —
Clinical Research Site Lauderhill Florida 33319 —
Clinical Research Site North Miami Florida 33161 —
Clinical Research Site Orlando Florida 32801 —
Clinical Research Site Atlanta Georgia 30328 —
Clinical Research Site Boise Idaho 83704 —
Clinical Research Site Chicago Illinois 60634 —
Clinical Research Site Boston Massachusetts 02131 —
Clinical Research Site Las Vegas Nevada 89102 —
Clinical Research Site Berlin New Jersey 08009 —
Clinical Research Site Cherry Hill New Jersey 08002 —
Clinical Research Site Toms River New Jersey 08755 —
Clinical Research Site Jamaica New York 11432 —
Clinical Research Site Rochester New York 14618 —
Clinical Research Site Staten Island New York 10312 —
Clinical Research Site Hickory North Carolina 28601 —
Clinical Research Site Cincinnati Ohio 45219 —
Clinical Research Site Middleburg Heights Ohio 44130 —
Clinical Research Site Oklahoma City Oklahoma 73112 —
Clinical Research Site Media Pennsylvania 19063 —
Clinical Research Site Philadelphia Pennsylvania 19104 —
Clinical Research Site Memphis Tennessee 38119 —
Clinical Research Site Dallas Texas 75243 —
Clinical Research Site Fort Worth Texas 76104 —
Clinical Research Site Houston Texas 77058 —
Clinical Research Site Wichita Falls Texas 76309 —
Clinical Research Site Everett Washington 98201 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04019704, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 12, 2022 · Synced Oct 16, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04019704 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →